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FDA Issues Warning About Tiagabine
February 23, 2005
February 22, 2005 -- FDA and Cephalon, Inc. notified healthcare professionals and the public that a Bolded Warning has been added to the labeling for Gabitril (tiagabine) to warn prescribers of the risk of seizures in patients without epilepsy being treated with Gabitril. FDA has received reports of the occurrence of seizures in more than 30 patients prescribed Gabitril for conditions other than epilepsy. Most of these uses were in patients with psychiatric illnesses. Such off label prescribing is a common practice among physicians. Because of the risk of seizures, however, in addition to adding the Bolded Warning to product labeling, the sponsor has agreed to undertake an educational campaign, targeted to healthcare professionals and patients, in which such off-label use will be discouraged.
To view the warning letters, click here.
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